NCT06454253

Brief Summary

The goal of this observational study is to evaluate the short-term outcomes and long-term outcomes of robot-assisted right colon group for cancer compared to laparoscopic-assisted right colon group. This is a large sample study based on ten years of clinical data. The main question it aims to answer is: What are the advantages of da Vinci robot right hemicolectomy compared to laparoscopic right hemicolectomy, and is there a difference in long-term efficacy between the two methods.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,879

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

9.3 years

First QC Date

May 29, 2024

Last Update Submit

June 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • overall survival

    months

    5 years after surgery

  • disease-free survival

    months

    5 years after surgery

Secondary Outcomes (8)

  • the rate of postoperative complications

    1 months after surgery

  • operative time

    Intraoperative

  • estimation of blood loss

    Intraoperative

  • number of retrieved lymph nodes

    Intraoperative

  • days after postoperative hospital stay

    1 months after surgery

  • +3 more secondary outcomes

Study Arms (2)

robot-assisted right colon group

Robot assisted radical surgery for right colon cancer

Device: Da Vinci Robot Surgical System

laparoscopic-assisted right colon group

Laparoscopic assisted radical surgery for right colon cancer

Device: Da Vinci Robot Surgical System

Interventions

Performing surgery on right colon cancer patients using the da Vinci robotic surgical system or laparoscopic surgical system

Also known as: Laparoscopic surgical system
laparoscopic-assisted right colon grouprobot-assisted right colon group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The consecutive cases of robotic-assisted or laparoscopic-assisted right colectomy between December 2014 and March 2024. All cases derived from the First Affiliated Hospital of Nanchang University.

You may qualify if:

  • The age is more than 18 years old and less than or equal to 85 years old
  • No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etc
  • Preoperative colonoscopy showing that the tumor was located in the ileocecal region, ascending colon, hepatic flexure, or transverse colon with pathology showing malignancy
  • signed informed consent. -

You may not qualify if:

  • multiple primary colorectal cancer
  • recurrent right colon cancer
  • preoperative neoadjuvant chemotherapy
  • emergency surgery for intestinal obstruction, bleeding or perforation
  • incomplete data and missing follow-up data. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
the First Affiliated Hospital of Nanchang University

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 12, 2024

Study Start

December 1, 2014

Primary Completion

March 31, 2024

Study Completion

April 30, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06